Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of clae in r/r t-all/lbl

Conditions: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Summary: to evaluate the efficacy and safety of clae regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory t-all/lbl.

this study is a prospective, open, multiple -centered, sing-arm trial. the major aim of this studies to evaluate the efficacy and safety of clae regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory t-all/lbl. the study will include 50 subjects to receive clae regimen for reinduction chemotherapy.

Eligibility criteria:
inclusion criteria: * diagnosis of t-acute lymphoblastic leukemia/lymphoblastic lymphoma according to world health organization (who) criteria which has relapsed or is refractory to chemotherapy. * age ≥ 18 years. * eastern cooperative oncology group (ecog) performance status ≤ 2. * the expected survival period is more than 12 weeks. * at least one measurable nidus * adequate organ function defined as: * calculated creatinine clearance ≥ 50 ml/min using the cockcroft -gault formula * ast, alt, total bilirubin ≤ 2 x upper limit of normal (uln) except for gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case alt and ast may be elevated up to ≤ 5 x uln. * able to understand and willing to sign an institutional review board (irb)-approved written informed consent document. exclusion criteria: * previous treatment with nelarabine or clofarabine or fludarabine or cladribine was ineffective. * pregnant or nursing. * received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks. * active hiv or hepatitis b or c infection. * any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment.

Keywords: r/r t-all/lbl clae
chemoradiotherapy with or without enteral nutrition for locally advanced thoracic esophageal carcinoma

Conditions: Esophageal Squamous Cell Carcinoma; Enteral Nutrition Therapy; Chemoradiotherapy

Summary: this is a randomized, prospective, multicenter study.

this is a randomized, prospective, multicenter study. the aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in locally advanced thoracic esophageal squamous cell carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.

Eligibility criteria:
inclusion criteria: * 18 to 75 years old * male or femalepathologically or cytologically proven esophageal squamous cell carcinoma * clinical stage ii or stage iii * pg-sga≧2 * karnofsky performance score(kps) ≧70 * estimated life expectancy of at least 12 weeks * hemoglobin≥90.0g/dl,white blood cell count（wbc）≥ 4000 cells/mm³,platelet count≥100,000 cells/mm³ * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 2.5 times upper limit of normal,bilirubin normal * creatinine normal or creatinine clearance ≥ 60 ml/min * patients have good compliance to treatment and follow-up of acceptance * forced expiratory volume in one second（fev1） ≥ 1.5 litre or ≥ 75% of the reference value * the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications exclusion criteria: * patients with severely bowel function impaired or can not tolerate enteral nutrition * patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted * patients have no risk of malnutrition * patients have severe malnutrition (weight loss \>10% or \<30 g/l, bmi\<18.5 kg/m2 or hemoglobin\<90 g/l before the treatment * patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction * patients can not tolerate chemotherapy and radiotherapy * patients who have distant metastasis * the primary tumor or lymph node already received surgical treatment (except for biopsy); * patient who received radiotherapy for primary tumor or lymph node; * patient who received chemotherapy or immunotherapy; * patient who suffered from other malignant tumor; * patient who have taken other drug test within 1 month; * pregnant woman or lactating women and women in productive age who refuse to take contraception in observation period; * subject with a severe allergic history or idiosyncratic; * subject with severe pulmonary and cardiopathic disease history; * refuse or incapable to sign the informed consent form of participating this trial; * drug abuse or alcohol addicted; * subject with a personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;
supreme lma and proseal lma in prone anesthetized patient

Conditions: Inadequate or Impaired Breathing Pattern or Ventilation

Summary: there is no significant difference about success rate of two devices.

there is no significant difference about success rate of two device: efficacy and safety

Eligibility criteria:
inclusion criteria: * american society anesthesiologists physical status i-iii * patient undergo elective orthopedics surgery in prone position under general anaesthesia exclusion criteria: * age \<15year * non-fast * morbid obesity (bmi \> 35kg/m2) * pregnancy * known or predicted difficult airway * gerd * history of laryngeal problem (injury,subglottic stenosis) * local pharyngeal problem (abscess,tumor) * poor dentation * pulmonary disease

Keywords: lma supreme,lma proseal,airway management,prone position
hypoxia and heart rate variability

Conditions: Pulmonary Disease, Chronic Obstructive; Hypoxia

Summary: the purpose of this study is to evaluate how variations in oxygen demands may change heart electrical activity in individuals with and without oxygen dependence.


Eligibility criteria:
healthy participants inclusion criteria: • ability to provide consent exclusion criteria: * bmi \> 40 kg/m2 * prevalent myocardial infarction, coronary revascularization, heart failure, and stroke * unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression) nocturnal hypoxemia inclusion criteria: * ability to provide consent * chronic respiratory condition resting sat \< 95% off oxygen exclusion criteria: * bmi \> 40 kg/m2 * prevalent myocardial infarction, coronary revascularization, heart failure, and stroke * unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
granisetron versus ondansetron for nausea and vomiting in pediatric age group

Conditions: Nausea and Vomiting in Pediatric Age Group

Summary: the current clinical trial will include 160 children who will be presented with vomiting to the outpatient department of the children's hospital, faculty of medicine, ain shams university. participants will be assigned randomly to receive either a dispersible film ondansetron or oral granisetron. after initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. the impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the functional living index-emesis (flie).


Eligibility criteria:
inclusion criteria: • patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration. exclusion criteria: * patients who are severely dehydrated. * patients who have bloody vomiting. * children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy. * patients who have vomiting due to surgical causes like intestinal obstruction.
in vivo proof-of-principle study of raman spectroscopy in trial participants with bladder tumours

Conditions: Endoscopic Bladder Cancer Diagnosis With Raman

Summary: the purpose with this clinical investigation is to perform raman spectroscopy inside the vivid bladder and to acquire raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.

the purpose with this clinical investigation is to perform raman spectroscopy inside the vivid bladder and to acquire raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the bladder tumor. the recordings and overall results will be compared to standard histo/cytopathological examination of urological tissue to achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and diagnostic information established by raman. the mib raman system in combination with a raman probe will be used in the operating theatre at herlev/copenhagen hospital urology department, where the rigid resectoscopes will be used while the trial participant is under general anesthesia. each measurement takes about 1-5 seconds and the whole procedure with the fiber optic probes is expected to prolong the operation with 10-15 minutes.

Eligibility criteria:
inclusion criteria: after booking for surgery the trial participants will be informed orally about the study and written material will be given by a doctor or nurse form the study group. if the trial participant accept to enter the study, written informed consent will be obtained. the trial participant will be informed that they can withdraw the informed consent at any time and the treatment will be according to the guidelines of the department. exclusion criteria: * macroscopic hematuria * pregnant or breast-feeding women * expected poor compliance * persons \< 18 years * persons who do not read or understand danish * dementia

Keywords: bladder cancer raman spectrometry in vivo diagnostics
study of fat malabsorption by lipiblock versus xenical

Conditions: Obesity

Summary: obesity is a chronic condition with fat-rich diets playing a major role in its etiology. pharmacological therapy has been proposed for weight loss and maintenance. this study aims to study the intestinal lipase blockade by partial inhibition of fat absorption after treatment with two commercials formulations of orlistat.

the overweight and obesity epidemic affects approximately 1.6 millions of people worldwide. obesity is a chronic condition, associated with premature death, co-morbidities, risk factors for main cardiac disease, stigmatization and significant economic costs. the causes of obesity are complex and include the interplay of environmental, social, economic and genetic factors. besides fat-rich diets also play a significant role in the etiology of obesity. correct diet orientation associated with physical exercise usually did not lead to expected result in weight loss and maintenance. pharmacological therapy has been proposed as an adjunct to achieve the ideal weight. orlistat acts in reduction of lipids absorption by inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained weight loss. this is a double blind study, randomized, of 2 weeks. the aim of this study was evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after treatment with two commercials formulations of orlistat in obese patients.

Eligibility criteria:
inclusion criteria: * obesity * bmc (body mass index) between 30 to 40 kg/m2 * women * 18 to 45 years * premenopausal stage exclusion criteria: * relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopathy or neoplasm in the last three years) * chemical or natural laxatives * weight variation greater than 5% in the preceding 3 months * surgery for weight reduction * drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months

Keywords: intestinal lipase orlistat fecal fat obesity
pseudohyponatremia of multiple myeloma is true hyponatremia

Conditions: Hyponatremia of Multiple Myeloma

Summary: hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma
aza + venetoclax as maintenance therapy in younger adults with aml in first remission

Conditions: Acute Myeloid Leukemia (AML) in Remission

Summary: this phase iii trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (rfs) for younger adults with favorable-risk acute myeloid leukemia (aml) who remained in first complete remission (cr1) following intensive consolidation.


Eligibility criteria:
inclusion criteria: 1. diagnosis of favorable-risk acute myeloid leukemia (aml) according to revised 2017 european leukemianet genetic risk stratiﬁcation and are not immediate candidates for allogeneic stem cell transplant. 2. aged 18-64 years. 3. patients who have received remission induction therapy and 3-4 hidac or medium-dose cytarabine-based consolidation and are in their first remission. 4. ecog performance status of \< or = 3. 5. adequate organ function as follows: 1. serum total bilirubin \< or = to 3 x the upper limit of normal (uln) 2. aspartate transaminase and alanine transaminase \< or = to 3 x uln 3. ccr（creatinine clearance rate) \> or ＝60 ml/min 4. left ventricular ejection fraction \> or ＝50% determined by ultrasound. 6. for females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling. 7. for males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment. 8. ability to understand and sign informed consent. exclusion criteria: 1. acute promyeloid leukemia. 2. patients with active central nervous system (cns) leukemia. 3. previously diagnosed with myelodysplastic syndrome (mds) or myeloproliferative neoplasm(mpn) and progressed to aml. 4. patients with other progressive malignancies. 5. evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal). 6. patients who have participated in other trials within 30 days before signing the informed consent. 7. females who are pregnant or lactating or intending to become pregnant during the study.
oral hyoscine butyl bromide versus diclofenac potassium before office hysteroscopy

Conditions: Endoscopy

Summary: the study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy


Eligibility criteria:
inclusion criteria: 1. patients that must perform a diagnostic hysteroscopy. 2. acceptance to participate in the study. 3. signed informed consent. 4. not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission. 5. absence of sedative use before admission exclusion criteria: 1. hypersensitivity to drugs 2. refusal of the patient 3. patients are pregnant.
study to evaluate safety and antitumor activity of lete-cel (gsk3377794) in hla-a2+ participants with ny-eso-1 positive previously untreated advanced (metastatic or unresectable) synovial sarcoma and myxoid/round cell liposarcoma

Conditions: Neoplasms

Summary: this trial will evaluate safety and efficacy of human engineered t-cell therapies, in participants with advanced tumors. this trial is a sub study of the master study nct03967223.


Eligibility criteria:
inclusion criteria: * participant must be greater than or equal to 10 years of age on the day of signing informed consent. * participant scheduled to receive clinical drug product supply must also weigh ≥40 kg * participant must be positive for hla-a\*02:01, hla-a\*02:05, and/or hla-a\*02:06 alleles by a designated central laboratory * participant's tumor is positive for ny-eso-1 expression by a designated central laboratory. * participant has a diagnosis of synovial sarcoma (ss) or myxoid/round cell liposarcoma (mrcls) * performance status: dependent on age - lansky \> 60, karnofsky \> 60, eastern * cooperative oncology group 0-1. * participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis. * at time of treatment, participant has measurable disease according to recist v1.1. * male or female. contraception requirements will apply at the time of leukapheresis and treatment. * consultation for prior history per protocol specifications. exclusion criteria: * central nervous system metastases. * any other prior malignancy that is not in complete remission. * clinically significant systemic illness (.(serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications) * prior or active demyelinating disease. * history of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments. * previous treatment with genetically engineered ny-eso-1-specific t cells. * previous ny-eso-1 vaccine or ny-eso-1 targeting antibody. * prior gene therapy using an integrating vector. * previous allogeneic hematopoietic stem cell transplant. * washout periods for prior radiotherapy and systemic chemotherapy must be followed. * participant had major surgery in less than or equal to 28 days of first dose of study intervention. * prior radiation exceeds protocol specified limits.

Keywords: adoptive t-cell therapy letetresgene autoleucel lete-cel gsk3377794
a school-based prevention intervention to promote wellbeing in preadolescents

Conditions: Major Risk Factors for Noncommunicable Diseases

Summary: this is a field study aiming to evaluate a school-based prevention intervention, diario della salute (dds).

diario della salute (dds) is a school-based prevention intervention based on the following theories: 1. social-cognitive theory (bandura, 1977; 1986) 2. theory of multiple intelligences (gardner, 1987) 3. emotional intelligence theory (goleman, 1997) 4. theory of planned behavior (ajzen, 1991) 5. transtheoretical model of change (prochaska, diclemente, 1982; 1992). dds is composed by: 1. tools for children and their parents on health and social and emotional well-being issues: 1. a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control), 2. a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.); 2. five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers. assignment of schools to study arms (dds intervention vs. no intervention) will be cluster-randomized. schools will be matched by number of students and average socioeconomic status. in some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools. two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. pre and post surveys will be linked through an anonymous code (galanti, 2006).

Eligibility criteria:
inclusion criteria: * schools providing consensus to study participation exclusion criteria: * schools involved in structured prevention programs with similar objectives

Keywords: universal prevention primary prevention health promotion wellbeing smoking alcohol diet physical activity emotional and social skills
chinese tatme registry collaborative

Conditions: Rectal Cancer

Summary: total mesorectal excision (tme) is the gold standard procedure for treating rectal cancer. however, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. transanal total mesorectal excision (tatme) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. so far, several studies have showed the promising results of tatme, but the multi-center data in china is still lacking. this nationwide registry study included more than 30 chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in chinese patients with rectal cancer and encouraging future research in this field.


Eligibility criteria:
inclusion criteria: * malignant or benign neoplasms of the rectum * the lower edge of the tumor from the anal margin less than 10cm according to mri or rigid endoscopy * tolerable to surgery * be able to understand and willing to participate in this registry with signature exclusion criteria: * patients requiring emergency surgery such as obstruction，perforation and bleeding * tumor involving adjacent organs, anal sphincter, or levator ani muscle * muti-focal colorectal cancer * preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence * history of inflammatory bowel disease or familial adenomatous polyposis * can not tolerate the surgery * history of serious mental illness * pregnancy or lactating women * preoperative uncontrolled infection * the researchers believe the patients should not enrolled in

Keywords: transnal total mesorectal excision rectal cancer